BioPharm International-10-01-2007

Regulatory agencies have evolved along with the biotechnology industry to define quality standards.

Low-pressure process chromatography could not have developed without immense efforts to resolve scale-up issues in both column design and matrix stability.

Thirty years after the first biotechnology company opened, the sector is reaching a new level of maturity and globalization.

Favrille, a San Diego-based biopharmaceutical company, is one of a handful of firms on the forefront of personalized medicine. Because personalized treatment is tailored to an individual's biology, it has the potential to be far more effective than current approaches to disease management.

One company even connected hollow fiber cell culture chambers to living cows.

There wasn't much of a contract services industry when BioPharm International began publishing 20 years ago. Today's big names in biomanufacturing, including Lonza, Boehringer-Ingelheim, and Avecia, had not yet entered the business.

It is commonly believed that technologies in the next 10–15 years will enable sequencing an individualized human genome for less than $1,000. With innovations like these, the twenty-first century will certainly belong to biotechnology. From an industrial standpoint, the discovery of therapeutic molecules and the development of cell lines and processes to produce these molecules will be of paramount importance. This article describes various approaches that have been prevalent in the industry or are likely to be used in the future for generating cell lines with desirable traits and developing high titer cell culture processes.

It became a strategic imperative to find a better, more efficient way to manufacture our products. To continue with the status quo was untenable.

Federal regulation of biologics began more than 100 years ago with the enactment of the Biologics Control Act of 1902. That act required licensing of establishments to manufacture and sell vaccines, sera, antitoxins, and other similar products in order to prevent deaths from contaminated vaccines, as had recently occurred with the diphtheria antitoxin.

In one series of experiments, the glycosylation site of IgG1 was removed and an IgA glycosylation site was introduced-resulting in a total loss of biological function.

Today, product costs, not process science, cause the most concern.

It is hoped that HIV patients' own immune responses can be strengthened by vaccines so they will not have to rely exclusively on antiretroviral drugs.

Multivariate data analysis can help biotech manufacturers deepen their process understanding.